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Trial Assessing AI-Aided Blood Test for Early Stage Cancer

Blood vials

(Ahmad Ardity, Pixabay)

28 Feb. 2022. A clinical trial is underway enrolling people with and without cancer to evaluate blood samples analyzed with artificial intelligence to detect early-stage cancer. Freenome Holdings Inc. in South San Francisco sponsors the trial to assess a diagnostic process that the company says uses multiple analytical techniques to detect multiple types of cancer.

Freenome aims to improve cancer diagnostics, making it possible to discover cancer earlier in the progress of the disease, when individuals have more treatment and prevention options. Many current screening methods, says the company, use simplified models to understand cancer, a dynamic, complex disease. In addition, says Freenome, physicians need to know more about the disease than just its presence or absence in the patient.

The company’s technology applies genomics, machine learning, and other computational techniques to analyze ordinary blood draws. Many liquid biopsies using blood samples, says Freenome, focus on a few genetic mutations suspected of causing a person’s cancer. Freenome says its process analyzes a wider range of molecular indicators in blood, looking for evidence of immune-system or metabolic changes, as well as DNA from cells emitted by a tumor. The company says its analytics identify signals and biomarkers not only detecting the presence of cancer, but also providing a more detailed picture of the condition for oncologists to prescribe precise treatments earlier in the disease.

Tested with colorectal and pancreatic cancer

Freenome published results from earlier studies of its diagnostic process on two forms of solid tumor cancer. In Jan. 2020, the company reported findings from a clinical trial that analyzed blood and stool samples from individuals tested for colorectal cancer, or CRC. The study team matched participants already diagnosed for CRC with average-risk individuals undergoing routine screening. Results, reported to a meeting of American Society of Clinical Oncology, show high true-positive sensitivity and true-negative specificity, both 94 percent, for early-stage CRC. The findings also show the Freenome test is more sensitive than other current tests analyzing blood and stool samples.

As reported by Science & Enterprise in Sept. 2021, another study shows the Freenome technology reveals individuals in early stages of pancreatic cancer, a form of cancer usually difficult to detect until its later stages. The study analyzed blood samples from 75 individuals with pancreatic ductal adenocarcinoma, or PDAC, the most common form of pancreatic cancer, tested with the Freenome process and the CA19-9 biomarker test used mainly to monitor disease progression. The combination of Freenome and CA19-9 tests produced an overall sensitivity of 93 percent, with 82 percent for early (stage 2) cases and 100 percent for late-stage cases, and an overall specificity of 96 percent.

The new case-control clinical trial is enrolling 5,400 participants in the U.S. age 30 and older, and like the CRC study, matching persons with cancer to healthy individuals, and taking blood samples for 12 months. Analytics from the blood samples are expected to show biomarkers and other indicators for specific cancer types or combinations of cancers. Freenome says more than 100 sites will conduct the study, but so far, only five locations are listed. The company titled the study Vallania after the mother of a Freenome scientist who died of pancreatic cancer.

“It’s been our plan from the beginning to extend our platform’s capabilities to include additional cancers beyond CRC,” says Freenome CEO Mike Nolan in a company statement released through Cision. Nolan adds, “The Vallania study is a key step in achieving that goal.”

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